Screen, Treat and Retain People With Primary Meth Use Disorder at MMT Clinics

NCT ID: NCT07121296

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2025-09-30

Brief Summary

This study is built upon the STAR-OM study (R01 DA050486) to assess if providing psycho-behavioral interventions and medications for people with primary methamphetamine use disorder (MUD) and without opioid use disorder (OUD) at methadone clinics is feasible and acceptable. In Vietnam and many U.S. settings, clinics providing medication for OUD (especially methadone clinics) are the only viable option for evidence-based addiction treatment. Importantly, many of these clinics are at primary care level and therefore accessible to people with primary MUD, who are in dire need for effective treatment. Furthermore, providers in methadone clinics are capable of conducting psycho-behavioral interventions, which remain the first line of treatment for MUD, and prescribing medications should these medications become available and approved by authorities. It remains unknown, however, if methadone clinics could serve as treatment facilities for those with primary MUD. This Supplement to the STAR-OM study will 1) assess the feasibility and acceptability of three recruitment strategies to enroll people with MUD and without OUD in MUD treatment at methadone clinics and 2) explore the feasibility and acceptability of providing psycho-behavioral interventions as well as challenges in providing medications at methadone clinics for people with MUD and without OUD. In Aim 1, the study will screen 600 people with primary MUD recruited through three strategies (peer outreach, snowballing and social media) over 3 months to enroll 60 people with MUD and without OUD into the study interventions. Participants will be screened at MMT clinics for meth use and readiness for MUD intervention. The study team will monitor recruitment rate for each strategy to assess feasibility. Acceptability will be assessed through focus group discussions with people who support recruitment (N=2 focus group with 12-16 participants), in-depth interviews with individuals eligible for enrollment and agree or decline to participate in the study interventions (N=15, 5 per recruitment strategy). In Aim 2, consenting participants will be randomized 1:1:1 into three arms of interventions over 12 weeks: (1) contingency management only; (2) group-based Matrix plus contingency management; and (3) individual-based Matrix plus contingency management. All participants will be required to provide urine samples randomly once a week. The investigators will monitor participation and retention rate in each treatment arm and completion of urine drug screens to assess feasibility. Acceptability will be assessed through post-intervention in-depth interviews with 15 participants, focus groups with methadone providers who deliver behavioral interventions (N = 1 focus group with 6-8 participants), and in-depth interviews with policy makers at national and city levels (N=5). In addition, participants will be asked in these interviews and focus groups about the challenges and facilitators of providing medications for treatment of MUD at MMT clinics should they become available. Findings from this Supplement will be used to prepare for a larger trial to assess effectiveness of implementing psycho-behavioral interventions for people with primary MUD and without OUD at methadone clinics.

Conditions

Methamphetamine Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contingency management for Substance use

Participants receive contingency management for their abstinence over 12 weeks

Group Type: EXPERIMENTAL

Contingency management for substance use

Intervention Type: BEHAVIORAL

Participants receive escalating incentives for each consecutive negative weekly urine drug screen.

Group-based Matrix plus contingency management

Participants receive group-based Matrix counseling and contingency management for their attendance in group counseling sessions

Group Type: EXPERIMENTAL

Contingency management for attendance

Intervention Type: BEHAVIORAL

Participants receive escalating incentives for each consecutive counseling session they attended.

Group-based Matrix counseling

Intervention Type: BEHAVIORAL

Group-based Matrix counseling

Individual-based Matrix plus contingency management

Participants receive individual-based Matrix counseling and contingency management for their attendance in individual counseling sessions

Group Type: EXPERIMENTAL

Contingency management for attendance

Intervention Type: BEHAVIORAL

Participants receive escalating incentives for each consecutive counseling session they attended.

Individual-based Matrix counseling

Intervention Type: BEHAVIORAL

Individual-based Matrix counseling

Interventions

Contingency management for substance use

Participants receive escalating incentives for each consecutive negative weekly urine drug screen.

Intervention Type: BEHAVIORAL

Contingency management for attendance

Participants receive escalating incentives for each consecutive counseling session they attended.

Intervention Type: BEHAVIORAL

Group-based Matrix counseling

Group-based Matrix counseling

Intervention Type: BEHAVIORAL

Individual-based Matrix counseling

Individual-based Matrix counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age: ≥ 18
• ASSIST ≥ 10 OR urine drug screen positive with meth
• Urine drug screen negative with opioid and methadone
• Willing to participate in study interventions at selected MMT clinics

Exclusion Criteria

• Unable to read and write Vietnamese
• Being incapable of understanding questions and research processes

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Hanoi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Giang Le Minh

Dean of the Institute of Preventive Medicine and Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giang M. Le, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hanoi Medical University

Locations

Hanoi Medical University

Hanoi, Hanoi, Vietnam

Countries

Vietnam

References

Des Jarlais DC, Arasteh K, Huong DT, Oanh KTH, Feelemyer JP, Khue PM, Giang HT, Thanh NTT, Vinh VH, Le SM, Vallo R, Quillet C, Rapoud D, Michel L, Laureillard D, Moles JP, Nagot N; DRIVE Study Team. Using large-scale respondent driven sampling to monitor the end of an HIV epidemic among persons who inject drugs in Hai Phong, Viet Nam. PLoS One. 2021 Nov 18;16(11):e0259983. doi: 10.1371/journal.pone.0259983. eCollection 2021.

Reference Type: BACKGROUND

PMID: 34793523 (View on PubMed)

Giang HT, Duc NQ, Khue PM, Quillet C, Oanh KTH, Thanh NTT, Vallo R, Feelemyer J, Vinh VH, Rapoud D, Michel L, Laureillard D, Moles JP, Jarlais DD, Nagot N, Huong DT. Gender Differences in HIV, HCV risk and Prevention Needs Among People who Inject drug in Vietnam. AIDS Behav. 2023 Jun;27(6):1989-1997. doi: 10.1007/s10461-022-03932-x. Epub 2022 Nov 28.

Reference Type: BACKGROUND

PMID: 36441408 (View on PubMed)

Bolivar HA, Klemperer EM, Coleman SRM, DeSarno M, Skelly JM, Higgins ST. Contingency Management for Patients Receiving Medication for Opioid Use Disorder: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2021 Oct 1;78(10):1092-1102. doi: 10.1001/jamapsychiatry.2021.1969.

Reference Type: BACKGROUND

PMID: 34347030 (View on PubMed)

Weinstock J, Alessi SM, Petry NM. Regardless of psychiatric severity the addition of contingency management to standard treatment improves retention and drug use outcomes. Drug Alcohol Depend. 2007 Mar 16;87(2-3):288-96. doi: 10.1016/j.drugalcdep.2006.08.027. Epub 2006 Sep 26.

Reference Type: BACKGROUND

PMID: 17005329 (View on PubMed)

Miguel AQ, Madruga CS, Cogo-Moreira H, Yamauchi R, Simoes V, da Silva CJ, McPherson S, Roll JM, Laranjeira RR. Contingency management is effective in promoting abstinence and retention in treatment among crack cocaine users in Brazil: A randomized controlled trial. Psychol Addict Behav. 2016 Aug;30(5):536-543. doi: 10.1037/adb0000192. Epub 2016 Jul 21.

Reference Type: BACKGROUND

PMID: 27442691 (View on PubMed)

Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

Reference Type: BACKGROUND

PMID: 10245370 (View on PubMed)

Chesney MA, Chambers DB, Kahn JO. Risk behavior for HIV infection in participants in preventive HIV vaccine trials: a cautionary note. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Dec 1;16(4):266-71. doi: 10.1097/00042560-199712010-00007.

Reference Type: BACKGROUND

PMID: 9402073 (View on PubMed)

Twitchell GR, Huber A, Reback CJ, Shoptaw S. Comparison of General and Detailed HIV Risk Assessments Among Methamphetamine Abusers. AIDS Behav. 2002;6(2):153-162. doi:10.1023/A:1015449231848

Reference Type: BACKGROUND

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

Reference Type: BACKGROUND

PMID: 2748771 (View on PubMed)

Le MTH, Tran TD, Holton S, Nguyen HT, Wolfe R, Fisher J. Reliability, convergent validity and factor structure of the DASS-21 in a sample of Vietnamese adolescents. PLoS One. 2017 Jul 19;12(7):e0180557. doi: 10.1371/journal.pone.0180557. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28723909 (View on PubMed)

McGregor C, Srisurapanont M, Mitchell A, Longo MC, Cahill S, White JM. Psychometric evaluation of the Amphetamine Cessation Symptom Assessment. J Subst Abuse Treat. 2008 Jun;34(4):443-9. doi: 10.1016/j.jsat.2007.05.007. Epub 2007 Jul 13.

Reference Type: BACKGROUND

PMID: 17629443 (View on PubMed)

Sobell LC, Sobell MB. Timeline follow-back: A technique for assessing self-reported alcohol consumption. In: Measuring Alcohol Consumption: Psychosocial and Biochemical Methods. Totowa, NJ, US: Humana Press/Springer Nature; 1992:41-72. doi:10.1007/978-1-4612-0357-5_3

Reference Type: BACKGROUND

Giang LM, Li MJ, Okafor CN, Diep NB, Shoptaw SJ. Correlates of methamphetamine use severity among patients receiving methadone maintenance treatment for opioid use disorder in Vietnam. J Subst Abuse Treat. 2022 Jan;132:108461. doi: 10.1016/j.jsat.2021.108461. Epub 2021 May 7.

Reference Type: BACKGROUND

PMID: 34098204 (View on PubMed)

Hoang TA. Civil society organisations' roles in health development in Vietnam: HIV as a case study. Glob Public Health. 2013;8 Suppl 1:S92-103. doi: 10.1080/17441692.2013.811530. Epub 2013 Jul 4.

Reference Type: BACKGROUND

PMID: 23822631 (View on PubMed)

Nguyen Bich D, Korthuis PT, Nguyen Thu T, Van Dinh H, Le Minh G. HIV Patients' Preference for Integrated Models of Addiction and HIV Treatment in Vietnam. J Subst Abuse Treat. 2016 Oct;69:57-63. doi: 10.1016/j.jsat.2016.07.003. Epub 2016 Jul 19.

Reference Type: BACKGROUND

PMID: 27568511 (View on PubMed)

Des Jarlais DC, Feelemyer J, Arasteh K, Huong DT, Oanh KTH, Khue PM, Giang HT, Thanh NTT, Moles JP, Vinh VH, Vallo R, Quillet C, Rapoud D, Michel L, Laureillard D, Nagot N; DRIVE Study Team. The methamphetamine epidemic among persons who inject heroin in Hai Phong, Vietnam. J Subst Abuse Treat. 2021 Jul;126:108320. doi: 10.1016/j.jsat.2021.108320. Epub 2021 Feb 4.

Reference Type: BACKGROUND

PMID: 34116818 (View on PubMed)

Giang LM, Trang NT, Thuy DT, Nguyen HH, Diep NB, Van HTH, Truc TT, Reback CJ, Li M, Van Dung D, Shoptaw S. Using ADAPT-ITT framework to tailor evidence-based interventions for addressing methamphetamine use among methadone patients in Vietnam. Drug Alcohol Rev. 2023 Nov;42(7):1667-1679. doi: 10.1111/dar.13739. Epub 2023 Aug 23.

Reference Type: BACKGROUND

PMID: 37614129 (View on PubMed)

Tran BX, Nguyen QL, Nguyen LH, Phan HTT, Le HT, Tran TD, Vu TTM, Latkin CA. Expanding co-payment for methadone maintenance services in Vietnam: the importance of addressing health and socioeconomic inequalities. BMC Health Serv Res. 2017 Jul 12;17(1):480. doi: 10.1186/s12913-017-2405-y.

Reference Type: BACKGROUND

PMID: 28701208 (View on PubMed)

Farhoudian A, Razaghi E, Hooshyari Z, Noroozi A, Pilevari A, Mokri A, Mohammadi MR, Malekinejad M. Barriers and Facilitators to Substance Use Disorder Treatment: An Overview of Systematic Reviews. Subst Abuse. 2022 Aug 29;16:11782218221118462. doi: 10.1177/11782218221118462. eCollection 2022.

Reference Type: BACKGROUND

PMID: 36062252 (View on PubMed)

Ginley MK, Pfund RA, Rash CJ, Zajac K. Long-term efficacy of contingency management treatment based on objective indicators of abstinence from illicit substance use up to 1 year following treatment: A meta-analysis. J Consult Clin Psychol. 2021 Jan;89(1):58-71. doi: 10.1037/ccp0000552.

Reference Type: BACKGROUND

PMID: 33507776 (View on PubMed)

Moszczynska A. Current and Emerging Treatments for Methamphetamine Use Disorder. Curr Neuropharmacol. 2021;19(12):2077-2091. doi: 10.2174/1570159X19666210803091637.

Reference Type: BACKGROUND

PMID: 34344291 (View on PubMed)

Han B, Compton WM, Jones CM, Einstein EB, Volkow ND. Methamphetamine Use, Methamphetamine Use Disorder, and Associated Overdose Deaths Among US Adults. JAMA Psychiatry. 2021 Dec 1;78(12):1329-1342. doi: 10.1001/jamapsychiatry.2021.2588.

Reference Type: BACKGROUND

PMID: 34550301 (View on PubMed)

Naji L, Dennis B, Rosic T, Wiercioch W, Paul J, Worster A, Thabane L, Samaan Z. Mirtazapine for the treatment of amphetamine and methamphetamine use disorder: A systematic review and meta-analysis. Drug Alcohol Depend. 2022 Mar 1;232:109295. doi: 10.1016/j.drugalcdep.2022.109295. Epub 2022 Jan 11.

Reference Type: BACKGROUND

PMID: 35066460 (View on PubMed)

Colfax GN, Santos GM, Das M, Santos DM, Matheson T, Gasper J, Shoptaw S, Vittinghoff E. Mirtazapine to reduce methamphetamine use: a randomized controlled trial. Arch Gen Psychiatry. 2011 Nov;68(11):1168-75. doi: 10.1001/archgenpsychiatry.2011.124.

Reference Type: BACKGROUND

PMID: 22065532 (View on PubMed)

Bakouni H, Sharafi H, Bahremand A, Drouin S, Ziegler D, Bach P, Le Foll B, Schutz CG, Tardelli V, Ezard N, Siefried K, Jutras-Aswad D. Bupropion for treatment of amphetamine-type stimulant use disorder: A systematic review and meta-analysis of placebo-controlled randomized clinical trials. Drug Alcohol Depend. 2023 Dec 1;253:111018. doi: 10.1016/j.drugalcdep.2023.111018. Epub 2023 Nov 4.

Reference Type: BACKGROUND

PMID: 37979478 (View on PubMed)

Coffin PO, Santos GM, Hern J, Vittinghoff E, Walker JE, Matheson T, Santos D, Colfax G, Batki SL. Effects of Mirtazapine for Methamphetamine Use Disorder Among Cisgender Men and Transgender Women Who Have Sex With Men: A Placebo-Controlled Randomized Clinical Trial. JAMA Psychiatry. 2020 Mar 1;77(3):246-255. doi: 10.1001/jamapsychiatry.2019.3655.

Reference Type: BACKGROUND

PMID: 31825466 (View on PubMed)

Knight R, Karamouzian M, Carson A, Edward J, Carrieri P, Shoveller J, Fairbairn N, Wood E, Fast D. Interventions to address substance use and sexual risk among gay, bisexual and other men who have sex with men who use methamphetamine: A systematic review. Drug Alcohol Depend. 2019 Jan 1;194:410-429. doi: 10.1016/j.drugalcdep.2018.09.023. Epub 2018 Nov 3.

Reference Type: BACKGROUND

PMID: 30502543 (View on PubMed)

AshaRani PV, Hombali A, Seow E, Ong WJ, Tan JH, Subramaniam M. Non-pharmacological interventions for methamphetamine use disorder: a systematic review. Drug Alcohol Depend. 2020 Jul 1;212:108060. doi: 10.1016/j.drugalcdep.2020.108060. Epub 2020 May 13.

Reference Type: BACKGROUND

PMID: 32445927 (View on PubMed)

Trivedi MH, Walker R, Ling W, Dela Cruz A, Sharma G, Carmody T, Ghitza UE, Wahle A, Kim M, Shores-Wilson K, Sparenborg S, Coffin P, Schmitz J, Wiest K, Bart G, Sonne SC, Wakhlu S, Rush AJ, Nunes EV, Shoptaw S. Bupropion and Naltrexone in Methamphetamine Use Disorder. N Engl J Med. 2021 Jan 14;384(2):140-153. doi: 10.1056/NEJMoa2020214.

Reference Type: BACKGROUND

PMID: 33497547 (View on PubMed)

Giang LM, Trang NT, Diep NB, Thuy DTD, Thuy DT, Hoe HD, Van HTH, Truc TT, Nguyen HH, Lai NL, Linh PTD, Vi VTT, Reback CJ, Leibowitz A, Li L, Lin C, Li M, Do Van Dung, Shoptaw S. An adaptive design to screen, treat, and retain people with opioid use disorders who use methamphetamine in methadone clinics (STAR-OM): study protocol of a clinical trial. Trials. 2022 Apr 23;23(1):342. doi: 10.1186/s13063-022-06278-w.

Reference Type: BACKGROUND

PMID: 35461300 (View on PubMed)

Other Identifiers

3R01DA050486-05S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3R01DA050486-05S1

Identifier Type: NIH

Identifier Source: org_study_id

View Link